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TGA Framework for COVID-19 Tests
Australia’s authority responsible for medical devices regulation, the Therapeutic Goods Administration (TGA), issued detailed guidelines on the regulatory approach to be applied to the test intended to identify the...
TGA Guidance on Thermometers
The Therapeutic Goods Administration (TGA), Australia’s authority responsible for medical devices regulation, issued guidance dedicated to thermometers and other temperature measuring devices in the context of the...
FDA Guidance on Electrosurgical Devices
The US Food and Drug Administration (FDA), the authority responsible for medical devices regulation, issued guidance dedicated to 510(k) premarket notification submissions for Electrosurgical devices for general...
Overview: FDA NESTcc Methods Framework
The National Evaluation System for Health Technology Coordinating Center (NESTcc), an organization created and supported by the US Food and Drug Administration (FDA) that focuses on the development of new approaches to...
FDA Guidance on CLIA Waiver Applications for IVDs
The US Food and Drug Administration (FDA), the authority responsible for medical device regulation, issued guidance intended to assist the manufacturers of In Vitro Diagnostic Devices (IVD) in filing applications for...